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New treatment option for Long COVID
Official title Effect of Hi-OxSR for the Treatment of Post COVID Condition
ClinicalTrials.gov ID: NCT06928506
What this study is testing
- What it's testing
- The RECLAIM study platform will be used to explore whether the use of the Hi-OxSR device improves the symptoms of post covid cognitive dysfunction. Carbon dioxide (CO2) has been proposed as a potential treatment for persistent immune activation as there is evidence that CO2 has antioxidant, anti-inflammatory, and anti-cytokine effects.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Age ≥18 years;
- Positive COVID-19 test by nasopharyngeal swab RT-PCR (reverse transcription polymerase chain reaction) test, antibody or antigen tests at least 3...
- Patients should be treated with standard of care therapies (as discussed in the study manual) for at least 4 weeks prior to entry into trial.
- Lingering COVID-19 symptoms beyond 3 months from onset of acute COVID and symptoms have lasted at least 2 months. The onset of COVID is considered...
- Lingering symptoms from COVID-19 present at the time of randomization. "Lingering symptoms of Long COVID" must include self-reported cognitive...
You likely can't join if
- Patients who had mechanical ventilation or extracorporeal membrane oxygen (ECMO) for COVID-19;
- Current end-organ failure, organ transplantation, or current hospitalization in acute care hospital;
- Contraindications to all of the study interventions;
- Co-enrolment in another treatment trial (co-enrolment in an observational study is permitted);
- Currently pregnant or breastfeeding.
- Known physician diagnosis of cognitive dysfunction prior to COVID infection
See the full eligibility criteria
- Age ≥18 years;
- Positive COVID-19 test by nasopharyngeal swab RT-PCR (reverse transcription polymerase chain reaction) test, antibody or antigen tests at least 3 months prior to randomization; OR Presumed COVID-19 assessed by the site...
- Patients should be treated with standard of care therapies (as discussed in the study manual) for at least 4 weeks prior to entry into trial.
- Lingering COVID-19 symptoms beyond 3 months from onset of acute COVID and symptoms have lasted at least 2 months. The onset of COVID is considered the earliest of two dates: the date of positive test or the date of...
- Lingering symptoms from COVID-19 present at the time of randomization. "Lingering symptoms of Long COVID" must include self-reported cognitive dysfunction symptoms.
- Female patients of childbearing potential (as assessed by the overseeing Investigator) who are sexually active must agree to practice true abstinence or use effective methods of contraception while on study treatment...
- Must be able to provide informed consent and both willing and able to comply with study requirements.
- Oxygen saturation on room air ≥92% at screening measured by pulse oximeter.
- Patients who had mechanical ventilation or extracorporeal membrane oxygen (ECMO) for COVID-19;
- Current end-organ failure, organ transplantation, or current hospitalization in acute care hospital;
- Contraindications to all of the study interventions;
- Co-enrolment in another treatment trial (co-enrolment in an observational study is permitted);
- Currently pregnant or breastfeeding.
- Known physician diagnosis of cognitive dysfunction prior to COVID infection
- Use of an investigational drug/device or other interventions within 30 days of screening
- Use of home oxygen (O2) at baseline
- History of pulmonary hypertension
- Interstitial pulmonary fibrosis
- Moderate to severe chronic obstructive pulmonary disease (COPD)
- History of narcolepsy
- Presence of a condition or abnormality that in the opinion of the investigator would compromise the safety of the participant or the quality of the data.
The study team makes the final eligibility decision.
Where it's taking place
- Edmonton, Alberta, Canada
- Toronto, Ontario, Canada
- Sherbrooke, Quebec, Canada
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Edmonton, Alberta, Canada; Toronto, Ontario, Canada; Sherbrooke, Quebec, Canada. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.